Search / Trial NCT00001316

Viral Load in Blood and Lymph Tissues of HIV-Infected Individuals

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

Trial Information

Current as of November 28, 2023

Recruiting

Keywords

Lymph Node Polymerase Chain Reaction (Pcr) In Situ Hybridization Aids Excisional Biopsy Natural History

Description

We are studying the pathogenesis of HIV infection and other immune dysfunctions. Because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood and lymphoid tissues cells for studying aspects of either in vivo or in vitro HIV infection. A dichotomy exists between the amount of HIV that can be measured in peripheral blood compared to lymphoid tissue, as well as the types of immune cells that reside in each compartment. We wish to be able to continue to elucidate many pathogenic aspects of HIV infection and other immune dysfunctions using human per...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA:
  • HIV infection must be documented by a licensed ELISA and confirmed either by Western blot, or plasma viremia.
  • Aged 18 years or older.
  • Ability to give informed, written consent.
  • The following laboratory values:
  • Absolute neutrophil count of greater than 1000/mm3.
  • PT, PTT within normal limits (unless PTT is elevated in presence of positive lupus anticoagulant in a subject with no prior history of abnormal bleeding).
  • Adequate blood counts (HIV positive volunteers: hemoglobin greater than or equal to 9.0 g/dL, HCT greater than or equal to 28%, platelets greater than or equal to 75,000; HIV negative volunteers: hemoglobin greater than or equal to 11.2 g/dL, HCT greater than or equal to 34.1%, platelets greater than or equal to 150,000).
  • Blood pressure less than or equal to 180/100; pulse rate 50-100, unless a lower pulse rate is considered normal for the volunteer.
  • HIV negative individuals will qualify as control subjects.
  • Patients must have a clinically palpable lymph node in an easily accessible location.
  • Willingness to allow blood samples to be used for future studies of HIV infection/pathogenesis, undergo genetic testing including HLA testing, and undergo hepatitis screening
  • EXCLUSION CRITERIA:
  • Women who are pregnant and/or breast-feeding.
  • Currently abusing alcohol or other drugs, including narcotics or cocaine.
  • Patients with AIDS dementia or with an AIDS related malignancy other than minimal Kaposi's sarcoma.
  • No Aspirin or Non-Steroidal Anti-inflammatory medications (NSIADs) 7 days prior to procedure. Acetaminophen (Tylenol) is permitted at any time.
  • Any medical condition for which the PI feels LN BX might be contraindicated.
  • Subjects in which sedation is planned. Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy will be excluded.

Attachments

readout_NCT00001316_2023-11-28.pdf

4.5 MB

NCT00001316_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Throughout

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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